Investigators

Project Overview

THE I-SPY TRIALS ARE AN UNPRECEDENTED AND STREAMLINED APPROACH TO CLINICAL TRIAL DESIGN.

I-SPY is a re-engineered approach to clinical trials. Our goal is to get the right drug to the right patient at the time they will benefit most and to do it much faster. The goal is to significantly reduce the overall cost, time, and number of patients required to bring new drugs to market.The I-SPY TRIAL Program integrates and links Phases I (I-SPY Phase 1), Phase II (I-SPY 2), and, eventually, Phase III (I-SPY 3) to build a pipeline of novel agents and accelerate the process of identifying the subset of high risk breast cancer patients that will benefit from these new agents, radiate it, and get the drug to market.

Biomarkers

standard biomarkers

Standard biomarkers, in clinical use or FDA-approved, used to determine patient eligibility and randomization.

qualifying biomarkers (hypothesis testing)

Biomarkers showing promise for predicting which patients will respond to which agents, but not yet FDA approved, will be evaluated under Clinical Laboratory Improvement Amendment (CLIA) quality standards.

exploratory biomarkers (hypothesis generating)

Biomarkers showing predictive or prognostic value for breast cancer treatment will also be investigated. Importantly, emerging platforms of the future can also be tested to prevent technology obsolescence even many years from now.

Trial Design

Questions?

To find out more about the I-SPY 2 TRIAL, or to request scientific documents and publications related to the Trial, please contact us at info@ispy2.org or use the form below.